Aurora, CONCT06918808Now EnrollingIRB Ready

Perianal Fistula Due to Crohn's Disease Clinical Trial in Aurora, CO

Access cutting-edge perianal fistula due to crohn's disease treatment through this clinical trial at a research site in Aurora. Study-provided care at no cost to qualified participants.

Sponsored by Direct Biologics, LLC

Quick Self-Assessment

See if you qualify for this Aurora location

Preparing your pre-screening questions…

Expert Care in Aurora

Access perianal fistula due to crohn's disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related perianal fistula due to crohn's disease treatment provided free

Apply for This Aurora Location

Check if you qualify for this perianal fistula due to crohn's disease clinical trial in Aurora, CO

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Aurora

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Aurora site if eligible
  4. 4Begin participation

About This Perianal Fistula Due to Crohn's Disease Study in Aurora

This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.

Sponsor: Direct Biologics, LLC

Who Can Participate

Inclusion Criteria

Written informed consent from participant
Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1
One or two perianal fistula(s) with 1 or two external openings, that are actively draining
Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)
Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula
Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)
Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) must have been stable for at least 2 weeks prior to Day 1
Oral corticosteroids ≤ 20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to Day 1
Approval of a screening pelvic MRI by review of a central radiologist. The definition of an acceptable screening pelvic MRI is provided in the study imaging manual.
Fulfillment of radiologic inclusion by a central radiologist. Radiologic inclusion on MRI is presence of 1 or 2 qualifying perianal fistula(s). Radiologic inclusion assesses anatomic criteria of a perianal fistula and study-defined imaging endpoint criteria. a. Anatomically, a qualifying perianal fistula on MRI fulfills the following from central radiologist assessment: i. has a communication with the internal sphincter of the anal canal ii. is classified as a Parks intersphincteric, transsphincteric, or suprasphincteric perianal fistula. b. For study imaging endpoints, a central radiologist confirms that a fistula has a minimum score of 7 (range 0 to 25) on MAGNIFI-CD and a fistula fibrosis -to-fluid ratio of less than 80%.25, 37 Within components of MAGNIFI-CD, the fistula has a length of 2.5 cm or greater and has a composition of either 'predominantly fluid/pus' or 'predominantly granulation tissue'. c. Within components of fistula fibrosis-to-fluid ratio, the ratio of hypointense scarring or fibrosis on MRI T2 weighted sequences to hyperintense fluid on MRI T2 weighted sequences is below 80%.25 The fistula is categorized into one of following ranges of fibrosis-to- fluid ratio: i) 0%, ii) 1-19%, iii) 20-39%, iv) 40-59%, or v) 60-79%

Exclusion Criteria

Lack of informed consent
Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
A participant who is unwilling to use medically acceptable contraception methods during participation in study
Active perianal abscess or infection at screening or Day 1
Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
Confirmed HIV, Hepatitis B, or Hepatitis C infections
History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
History of colorectal cancer within 2 years of screening
History of coagulation disorders and/or are currently on anti- coagulant therapy
Presence of a recto/ano-vaginal fistula
Presence of an ileal anal pouch and/or history of proctectomy
Presence of severe proctitis (SES CD \>6)
Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for participant to undergo MRI evaluations (i.e., presence of implantable or external MRI unsafe device that cannot be removed, body weight exceeding limitations, claustrophobia, etc.)
The following out of range laboratory results at screening
WBC \> 13 x 109 /L
Hemoglobin \< 8 g/dL
Platelet count \< 100,000/mL
AST/ALT \> 3 times the upper limit of normal
Creatinine \> 2 μmol/L
PT/INR: 2 times the upper limit of normal
Hemoglobin A1c \> 6.5 mg/dL
Use of investigational therapy or treatment within 30 days prior to Day 1
Does not meet the radiologic anatomic inclusion criteria: i) has a primary communication with the rectum and not the anal canal; ii) is classified as a Parks extrasphincteric fistula
Does not meet the minimum thresholds for the radiologic imaging endpoint inclusion criteria: i) has a MAGNIFI-CD score of \<7 (range 0-6) on screening pelvic MRI; ii) has a fibrosis-to-fluid ratio of 80% or more (range 80-100%) on screening pelvic MRI

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT06918808) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Perianal Fistula Due to Crohn's Disease Treatment Options in Aurora, CO

If you're searching for perianal fistula due to crohn's disease treatment options in Aurora, CO, this clinical trial (NCT06918808) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced perianal fistula due to crohn's disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all perianal fistula due to crohn's disease clinical trials near you to find additional studies recruiting in your area.

More Pulmonary Embolism Trials in Aurora, CO

See all pulmonary embolism clinical trials recruiting in Aurora — not just this study.

Browse Pulmonary Embolism Trials in Aurora →

Browse More Trials by Condition

Pulmonary Embolism TrialsCrohns Disease TrialsAnkylosing Spondylitis TrialsInflammatory Bowel Disease TrialsAll Conditions →

Ready to Join in Aurora?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Aurora, CO